A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

Phase 3

Completed

Conditions: Ophthalmic Solutions

Interventions: Drug: F#13418-158 Eye Drops
Drug: F# 13418-148 Eye Drops
Drug: F# PF-004390 Eye Drops

Registration Number: NCT03198000

Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Brief Summary: This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.

Detailed Description: Eligible participants will use assigned eye drop products as directed. Participants will be required to attend 2 consecutive clinic visits. Assessments for eye redness and eye comfort will be completed. Participants will complete brief questionnaires about their eyes.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

Inclusion Criteria

Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
Male or female of any race or ethnicity, aged 18 years and older;
Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
Able to read and understand English;
Healthy subjects with redness in both eyes
History of topical ocular drugs or desire to use within the last 6 months;
Ocular health within normal limits,
Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.

Exclusion Criteria

Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
Known sensitivity, allergy or contraindications to any investigational product ingredient;
Females who are pregnant, planning to become pregnant or breastfeeding during the study;
Subjects who were previously screened and determined to be ineligible for the study;
Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation;
Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
Relative, partner or staff of any clinical research site personnel;
Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection;
Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
Has a compromised immune system;
Has any acute or chronic, medical or psychiatric conditions
Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formula # 13418-158	F#13418-158 Eye Drops	-
Formula # 13418-148	F# 13418-148 Eye Drops	-
Control Formula # PF004390	F# PF-004390 Eye Drops	-

Primary Outcome Measures

Name	Time	Method
Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application	Baseline to 60 seconds after first product application	Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
Percentage of Participants With Response to Redness at 60 Seconds After First Product Application	Baseline to 60 seconds after first product application	The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Ocular Comfort at 10 Hours After First Product Application	Baseline to 10 hours after first product application	Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.
Change From Baseline in Ocular Comfort at 12 Hours After First Product Application	Baseline to 12 hours after first product application	Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.
My Eye Appears to Sparkle - 10 Hours After First Application	10 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Clinician Assessment of Baseline Redness	Baseline	Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
My Eye Feels Hydrated - 2 Minutes After First Application	2 minutes after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Feels Refreshed - 2 Minutes After First Application	2 minutes after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application	Baseline to 60 seconds after first product application	Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.
My Eye Feels Hydrated - Baseline	Baseline	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application	2 minutes after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application	10 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application	12 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application	Baseline to 30 seconds after first product application	Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application	Baseline to 2 minutes after first product application	Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
My Eye Feels Hydrated - 10 Hours After First Application	10 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Feels Hydrated - 12 Hours After First Application	12 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Feels Refreshed - 10 Hours After First Application	10 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application	12 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Feels Cool - 12 Hours After First Application	12 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Feels Refreshed - 12 Hours After First Application	12 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application	2 minutes after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application	10 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Appears Healthy - 2 Minutes After First Application	2 minutes after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Feels Cool - 2 Minutes After First Application	2 minutes after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
The Appearance of my Eye Gives me Confidence to Approach Others - Baseline	Baseline	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
The Appearance of my Eye Can Show How I Really Feel - Baseline	Baseline	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Appears Healthy - Baseline	Baseline	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Appears Healthy - 10 Hours After First Application	10 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Appears Healthy - 12 Hours After First Application	12 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Feels Cool - 10 Hours After First Application	10 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Appears to Sparkle - Baseline	Baseline	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Appears to Sparkle - 12 Hours After First Application	12 hours after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
My Eye Appears to Sparkle - 2 Minutes After First Application	2 minutes after first application	Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.